Healthy VolunteersPhase 1NCT06761898
A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants
A Phase 1 study testing BGB-43395 in people with Healthy Volunteers, run by BeiGene at 1 site in United States.
Trial summary
Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in Part 1 and the effect of food on the selected BGB-43395 formulation solid dispersion tablet or salt tablet in healthy adult participants in Part 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BGB-43395
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2025to 20 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, of any race, between 18 and 65 years of age
- Body mass index between 18.0 and 32.0 kg/m2, inclusive
- In good health, as determined by no clinically significant findings from medical history
- Able to comprehend and are willing to sign the ICF and abide by the study restrictions
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
- Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, or pulse rate >100 or <40 beats per minute. If any parameter is out of range, measurements should be repeated twice. Participants will be excluded if the average of the 3 measurements are outside of the corresponding reference range.
- History of prolonged QT interval/QT interval corrected for heart rate, with QTcF >450 ms for males and >470 ms for females.
- History or current diagnosis of diabetes, with a HbA1c ≥6.5% or fasting blood glucose level ≥126 mg/dL at screening alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >1.5 × upper limit of normal (ULN) (except for participants with Gilbert's syndrome, where total bilirubin should not be >2 × ULN) at screening and check-in.
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- eGFR <90 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021)
- Hemoglobin <lower limit of normal (LLN), white blood cell count <LLN, absolute neutrophil count <LLN, or platelet count <LLN at screening and check-in.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Cru, Daytone Beach
Daytona Beach, Florida, 32117-5116
About this study
Official title: A Phase 1, Open-label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Two Tablet Formulations and the Effect of Food on the Pharmacokinetics of a Single Oral Dose of BGB-43395 in Healthy Participants
Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in Part 1 and the effect of food on the selected BGB-43395 formulation solid dispersion tablet or salt tablet in healthy adult participants in Part 2.
- Conditions
- Healthy Volunteers
- Being tested
- BGB-43395
- Keywords
- BGB-43395, Relative Bioavailability, Effect of Food, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-43395Drug
Administered orally as solid dispersion tablet or salt tablet
BGB-43395Drug
Administered orally as solid dispersion tablet or salt tablet
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Relative Bioavailability | Experimental | Participants will receive a single dose of each formulation of BGB-43395 in separate periods across various sequences. Receives: Drug: BGB-43395 |
| Part 2: Food Effect | Experimental | Participants will receive three doses of the selected formulation of BGB-43395 under fasted, low-fat, or high-fat conditions in separate periods across various sequences. Receives: Drug: BGB-43395 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and 2: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
Measured: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Measured: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Maximum Observed Concentration (Cmax)
Measured: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Time of the Maximum Observed Concentration (Tmax)
Measured: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Terminal Elimination Half-life (t1/2)
Measured: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Total Clearance (CL/F)
Measured: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Volume of Distribution (Vz/F)
Measured: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Secondary outcomes (4)
Number of Participants with Adverse Events (AEs)
Measured: Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant laboratory values
Measured: Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant electrocardiogram (ECG) results
Measured: Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant vital sign measurements
Measured: Approx 38 days in Part 1 and 45 days in part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start14 Jan 2025
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761898
- Sponsor's protocol ID
- BGB-43395-103
- Status last verified
- Aug 2025
- First submitted
- 31 Dec 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Two Tablet Formulations and the Effect of Food on the Pharmacokinetics of a Single Oral Dose of BGB-43395 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06761898
- Acronym / sponsor ID
- BGB-43395-103
- Conditions
- Healthy Volunteers
- Keywords
- BGB-43395, Relative Bioavailability, Effect of Food, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in Part 1 and the effect of food on the selected BGB-43395 formulation solid dispersion tablet or salt tablet in healthy adult participants in Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Relative Bioavailability | Experimental | Drug: BGB-43395Participants will receive a single dose of each formulation of BGB-43395 in separate periods across various sequences. |
| Part 2: Food Effect | Experimental | Drug: BGB-43395Participants will receive three doses of the selected formulation of BGB-43395 under fasted, low-fat, or high-fat conditions in separate periods across various sequences. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, of any race, between 18 and 65 years of age
- Body mass index between 18.0 and 32.0 kg/m2, inclusive
- In good health, as determined by no clinically significant findings from medical history
- Able to comprehend and are willing to sign the ICF and abide by the study restrictions
Key exclusion criteria (10 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
- Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, or pulse rate >100 or <40 beats per minute. If any parameter is out of range, measurements should be repeated twice. Participants will be excluded if the average of the 3 measurements are outside of the corresponding reference range.
- History of prolonged QT interval/QT interval corrected for heart rate, with QTcF >450 ms for males and >470 ms for females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-43395Administered orally as solid dispersion tablet or salt tablet | Drug | Part 1: Relative Bioavailability |
| BGB-43395Administered orally as solid dispersion tablet or salt tablet | Drug | Part 2: Food Effect |
Primary outcome
Part 1 and 2: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Maximum Observed Concentration (Cmax)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Time of the Maximum Observed Concentration (Tmax)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Terminal Elimination Half-life (t1/2)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Total Clearance (CL/F)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Volume of Distribution (Vz/F)
Time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
4 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant laboratory values
Time frame: Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant electrocardiogram (ECG) results
Time frame: Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant vital sign measurements
Time frame: Approx 38 days in Part 1 and 45 days in part 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Yes
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director Study Director study director
BeiGene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-43395 in people with Healthy Volunteers, run by BeiGene at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 and 2: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) (time frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.